Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis

N/ANot Yet RecruitingNCT06870305

Centre Psychothérapique de Nancy270 enrolled

Overview

The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

270

Conditions

Clinical High Risk for Psychosis (CHR)

Interventions

The group-based mindfulness programme is called MBTP (Mindfulness based training for psychosis). The MBTP programme consists of 5 sessions over a period of one month (2 sessions in the first week, then one session a week). Each session lasts approximately 1h30 and is carried out in a group of 5 participants. The sessions cover informal and formal mindfulness tasks, elements of psycho-education on emotions, meditation exercises on emotions, and thought defusion and acceptance tasks. Participants are encouraged to meditate at home between sessions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score) Exclusion Criteria: * Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder * Previous antipsychotic treatment for more than 12 months * Organic mental disorder or intellectual disability * Serious suicidal/homicidal risk (but admissible if this risk has been resolved) * Insufficient French language skills * Adult incapable of giving consent and not under legal protection * Protection measure (guardianship/curatorship/court supervision) or under court supervision * Person deprived of liberty by judicial or administrative decision (including forced hospitalisation) * Persons in a life-threatening emergency * Not affiliated to a social security regime

Locations (2)

Centre Hospitalier Universitaire (CHU) de Brest

Brest, France

Centre Psychothérapique de Nancy

Laxou, France

Outcomes

Primary Outcomes

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame: 3 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame: 4 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame: 6 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame: 9 months

Secondary Outcomes

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame: 3 months

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame: 4 months

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame: 6 months

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame: 9 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale

Time frame: 3 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale

Time frame: 4 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale

Time frame: 6 months

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale

Time frame: 9 months

Number of patients making a transition to psychosis

Time frame: 3 months

Number of patients making a transition to psychosis

Time frame: 4 months

Number of patients making a transition to psychosis

Time frame: 6 months

Number of patients making a transition to psychosis

Time frame: 9 months

Cognitive functions

Cognitive functions measured by the Attentional Performance Tests (APT)

Time frame: 3 months

Cognitive functions

Cognitive functions measured by the Attentional Performance Tests (APT)

Time frame: 4 months

Cognitive functions

Cognitive functions measured by the Attentional Performance Tests (APT)

Time frame: 6 months

Cognitive functions

Cognitive functions measured by the Attentional Performance Tests (APT)

Time frame: 9 months

Cognitive functions

Cognitive functions measured by the California Verbal Learning Test (CVLT)

Time frame: 3 months

Cognitive functions

Cognitive functions measured by the California Verbal Learning Test (CVLT)

Time frame: 4 months

Cognitive functions

Cognitive functions measured by the California Verbal Learning Test (CVLT)

Time frame: 6 months

Cognitive functions

Cognitive functions measured by the California Verbal Learning Test (CVLT)

Time frame: 9 months

Anxiety

Anxiety measured by the State Trait Anxiety Inventory (STAI)

Time frame: 3 months

Anxiety

Anxiety measured by the State Trait Anxiety Inventory (STAI)

Time frame: 4 months

Anxiety

Anxiety measured by the State Trait Anxiety Inventory (STAI)

Time frame: 6 months

Anxiety

Anxiety measured by the State Trait Anxiety Inventory (STAI)

Time frame: 9 months

Functioning

Functioning measured by the Personal and Social Performance Scale (PSP)

Time frame: 3 months

Functioning

Functioning measured by the Personal and Social Performance Scale (PSP)

Time frame: 4 months

Functioning

Functioning measured by the Personal and Social Performance Scale (PSP)

Time frame: 6 months

Functioning

Functioning measured by the Personal and Social Performance Scale (PSP)

Time frame: 9 months